FDA panel backs omadacycline for pneumonia

September 14, 2018 0 By CH Unnikrishnan

The Antimicrobials Drug Advisory Committee of the USFDA voted in favour of the approval of omadacycline for the treatment of acute bacterial skin structure infections and community-acquired bacterial pneumonia,  Paratek Pharmaceuticals, Inc. announced.

Omadacycline is a modernized tetracycline being developed as a once-daily IV and oral, broad spectrum antibiotic for the treatment of serious community-acquired infections.Omadacycline is specifically designed to overcome tetracycline resistance and exhibits activity across a broad spectrum of bacteria, including Gram-positive, Gram-negative, anaerobes, atypical bacteria, and other drug-resistant strains.

The advisory committee considered data from the omadacycline global development programme, which included three completed Phase 3 studies evaluating the safety and efficacy of the IV and oral formulations of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP). In all three studies, omadacycline met all primary and secondary efficacy outcomes designated by the FDA and was generally safe and well-tolerated.

Under a research agreement with the U.S. Department of Defense, omadacycline is also being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.